ATEMPT Clinical Trial - Roll Call
Comments
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Hi NCGirl68,
My annual checkup is this July at Dana Farber, where the study began. I'll be asking about results but we shouldn't expect to know too much (if anything) till 2020, based on info at the homepage for the trial. It says:
January 2020 (Final data collection date for primary outcome measure)
Here's the link: https://clinicaltrials.gov/ct2/show/record/NCT01853748
The only thing my onc told me last time was in general everyone's doing great--not exactly a scientific measurement but encouraging!
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Thanks IsabelArcher - that is encouraging - guess we have to wait until 2020.
I have another question for anyone here....I recently had reconstruction on my mastectomy side - 4 years later and LOVE IT! My plastic surgeon wants to use half of my nipple from my good breast for the other side - has anyone done this? I would get the aerola tattoo on.....I know they often nipple reconstruction but she thinks my one nipple is good enough (big enough) to spare half - I like this idea because right now - even through some clothes it's noticeable that it's just one nipple....
Glad everyone is doing well....
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Hi NCGirl-- I haven't heard of that method of nipple reconstruction. Surgeons are always coming up with new ideas, I guess! My Frankenboob is blank--no nip--but I don't have trouble concealing this in my bra. One of these days I might get the organic boob lifted and then a nip tattoo on the new boob, so they'll match. But I might also just never do it. I'm not bothered enough, I guess.
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Hi everyone! I hope you’re all well. Those are very good findings so far on T-DM1!
I saw my MO at Dana Farber in April. All A-OK!! Such a relief! Anyway, she said it would be about a year before the results of the trial will come out, so yes, early 2020.
NCGirl, I had reconstruction done during the time I was in treatment, but no nipple. I have not heard of using one to make another! I plan to get a 3D nipple tattoo later in the fall. The Vinny Meyers group from Baltimore comes here to Boston several times a year to do these. I found out my insurance will cover the cost as part of reconstruction, so that finally convinced me to get it done. I just don’t want to get a tattoo in the hot summer months!
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Serenity, I will be very interested to hear about the 3D nipple after you get it! My mammo at DF is July 31. Trying to keep the anxiety dogs quiet till then!
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Ladies-- I had my mammo this week, and it was all clear. Phew! I handled it better this time--the super-insane anxiety didn't hit till after the mammo and waiting to hear what the radiologist would say. Usually I start to feel panicked the minute I wake up on the day of the test. Progress!
My MO said that results of the trial will be presented at the December 2019 San Antonio breast cancer conference--the big one. My MO's Dana Farber colleague, Sara Tolaney, is the lead (or one of the lead) researchers on the trial, but my MO said even though they work side by side she herself doesn't know what the report will say. She told me it would certainly be in the news.
My MO recommended that I go in for genetic testing again. I had it in 2014 and am BRCA negative, but at that time there wasn't much point in getting tested for other gene mutations as there was little known about which ones correlate with increased risk of cancer. My doc said there's been a lot of progress in the last couple of years, and getting more info on gene variants/mutations could be good to have. So I would get tested for a larger "panel" of possible mutations. I'm not too happy about this--I still feel like having knowledge of bad genes will just give me little panics at 4 am, but I trust my doc and she was quite firmly on the side of getting more info.
Has anyone else done this recently?
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Trial results will be available in December? That's only 4 short months away. Great. My MO thought we'd have to wait until the Spring.
Congratulations Isabel! I went in for my routine mammo and ultrasound on Wednesday and I also heard the "all clear" results.
While I was waiting for my mammo, the tech told me about the Myriad MyRisk Genetic Testing that is available and handed me a Patient's Guide to Hereditary Cancer and Genetic Testing brochure. This Hereditary Cancer Panel test looks for multiple genetic mutations associated with increased cancer risk for 8 different cancers (breast, ovarian, colorectal, endometrial, melanoma, pancreatic, gastric, prostate, other cancers) by checking 30 different genes. I thought this was an interesting test to take since I am the first person in my immediate family to have breast cancer. I went ahead and provided them with a saliva sample and I will have the results of this test in mid-September.
This is the only genetic test I have had. Is this the same test you had? Has anyone had a genetic test done?
Happy to hear that everyone is doing so well.
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Tiny, congrats to you too! I don't remember what my 2014 genetic test was called--it was limited to BRCA and a few other genes, because I declined to be tested for the larger panel. If I have another one as my MO suggests, it would be for the larger panel--probably like what you just had. My mother died of BC in 1994, and my older brother recently had prostate cancer (it was early, and he's fine), so we do have a heightened cancer risk in my family. My gene testing would be a help to the next generation.
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Tiny and Isabel congratulations on a clean bill.
I am now two years post Kadcyla/Herceptin therapy and almost three years post radiation. And now see someone every six months. So far all is well and am looking forward to hearing the results especially since I only received the Kadcyla for about five months.
So far being in my 60’s sucks. My past has caught up with me and I are making arrangements for a knee replacement. My injury occurred around 1980 during skiing. First I’m supposed to loose weight. It took chemo last time I lost weight. So I am not very hopeful on the outcome
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I have the results of that genetics test I took back in August. Of the 30 genes it tested, I have the gene "BRIP1" = ovarian cancer. So, it is possible that I will get it in the future. I spoke to my Gyno and MO both said "remove your ovaries and tubes". I met with a Gyno/Onc to discuss the results and my cancer history and I am scheduled for surgery in January to have my ovaries and tubes removed. Then I will be on an AI. While I've been on Tamoxifen for almost 4 years, my hot flashes have not been bad - just a few while sleeping. I am not looking forward to worsening side effects. Also want my mojo back. Is one AI SE's better than the other? Any suggestions?
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Also, I have been looking for a deodorant without aluminum that really works and keeps me dry. I've tried Tom's and Dove 0, but they do not work. What are you all using
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Tiny Dancer, On one hand I'm really sorry to hear you have the BRIP1 gene, but on the other, I'm really glad testing found it and you can do something about it! I had never heard of it till reading your post just now. I have still not made my appt. for the larger-panel gene test as recommended by my onc. Guess I'd better do it already. Will your surgery be laparoscopic or regular?
I was on Tamoxifen for a few years and then went to Anastrozole (AI), but only briefly. I'm sorry to say I had a bad SE of painful joints. I'm so weakly ER-positive in any case that my onc took me right off it again and that was that. I don't know if Letrozole is any better or worse. It will probably be trial and error for you. With luck it will not affect you negatively!
(As for your other question about deodorants--I just use regular Dove, so I can't offer any advice on that.)
Thanks for reporting on your genetic testing and lighting a fire under my butt to get it done. Best of luck to you!!!
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Hi Isabel, Yes my surgery will be laparoscopic. My gyno onc said that "OC is worse than BC and there is no cure for it". So they are coming out before they cause any problems. I'm 55 and don't need them anyway. I found out last month that my sister has DCIS ER+, PR+ and will only need radiation treatments. I am so happy she doesn't need any chemo.
Deodorants - I use regular secret, but yeah I'm still looking for one without aluminum.
The San Antonio Breast Cancer Conference is next week and I'm hoping we will find out about the trial results.
Happy Holidays to everyone!
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2019 SABCC abstracts list...search results for "atempt".....
- Dec 12 2019 7:00AM
P2-13-02. Chemotherapy-related amenorrhea (CRA) after adjuvant trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT trial)
Bookmark - Dec 11 2019 8:45AM
GS1-05 . TBCRC 033: A randomized phase II study of adjuvant trastuzumab emtansine (T-DM1) vs paclitaxel (T) in combination with trastuzumab (H) for stage I HER2-positive breast cancer (BC) (ATEMPT)
Bookmark - Dec 13 2019 7:00AM
PD10-02. Patient reported outcomes from the adjuvant trastuzumab emtansine (T-DM1) vs. paclitaxel + trastuzumab (TH) (ATEMPT) trial (TBCRC 033)
0 - Dec 12 2019 7:00AM
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Thanks MaggieCat!
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Thanks, MaggieCat. I got nervous seeing those dates for presentation of the ATEMPT results!
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Will check next week and post if more information is available for the 12/11/2019 general session presentation. Typically SABCC has the full abstract on-line for general session presentations.
My 5 year check-up was at the end of November. The trial follows us for 5 years so I've reached that milestone. Was told that all of the participants at my treatment center are doing well thus far!0 -
Here is the abstract ....
GS1-05 . TBCRC 033: A randomized phase II study of adjuvant trastuzumab emtansine (T-DM1) vs paclitaxel (T) in combination with trastuzumab (H) for stage I HER2-positive breast cancer (BC) (ATEMPT)
December 11, 2019, 9:45 AM - 10:00 AM- Abstract
- Background: The APT trial previously demonstrated that adjuvant TH is associated with favorable outcomes in patients (pts) with small HER2-positive BC. The ATEMPT trial sought to determine if adjuvant T-DM1 is associated with less toxicity than TH, and if it is associated with a clinically acceptable disease-free-survival (DFS) in pts with Stage I HER2+ BC.
Methods: ATEMPT is an investigator-initiated, randomized, multicenter, phase II adjuvant study of T-DM1 vs TH. Pts with Stage I centrally confirmed HER2+ BC (IHC 3 + and/or FISH > 2.0) were eligible. Pts were randomized 3:1 to T-DM1 or TH and received T-DM1 3.6 mg/kg IV every 3 weeks (w) for 17 cycles or T 80 mg/m2 IV with H qw x 12w (4 mg/kg load →2 mg/kg), followed by H x 39w (6 mg/kg q 3w). The co-primary endpoints were to compare the incidence of clinically relevant toxicities (CRT) in pts treated with T-DM1 vs TH and to evaluate the DFS in pts receiving T-DM1. CRT included grade ≥3 non-hematologic toxicity, grade ≥2 neurotoxicity, grade ≥4 hematologic toxicity, febrile neutropenia, and any toxicity requiring dose delay or discontinuation of protocol therapy. DFS events included invasive local, regional or distant recurrence, contralateral invasive breast cancer or death from any cause. With 375 and 125 pts randomized to T-DM1 and TH, respectively, there was 81% power to detect a 40% relative reduction in CRT between T-DM1 and TH. An interim analysis for comparison of CRT was performed when two-thirds of pts had completed therapy. For evaluation of DFS, the study was sized to have 95% power to distinguish between 3-year failure rates of 9% vs. 5% based on the total patient-years of follow-up (PYFU). Planned interim analyses were designed to stop early for futility at 186, 486, 861, and 1236 PYFU, and T-DM1 would be deemed worthy of further study with <39 DFS events after 1600 PYFU. All pts who began protocol therapy were included in the analyses.
Results: 512 pts with HER2+ tumors were enrolled and 497 began protocol therapy (383 T-DM1, 114 TH). 73% had hormone-receptor positive tumors. 11% of tumors were T1a; 31% T1b; 57% T1c. After interim analyses and continued review of safety, the Data Safety Monitoring Board approved release of study results. CRT were experienced by 25% of pts receiving T-DM1 and 36% of patients receiving TH; the difference was statistically significant (p=.03) but the relative reduction was < 40% (p=0.95). 2% (9/383) of pts receiving T-DM1 experienced g3/4 neurotoxicity compared to 7% (8/114) of pts receiving TH; 17% of pts discontinued T-DM1 early due to adverse events. With 1562 PYFU and a median follow-up of 3.0 years, a total of 11 DFS events in the T-DM1 arm (1 distant recurrence, 3 local recurrences, 3 contralateral breast cancers, 1 death due to recurrent breast cancer, 3 deaths from other causes) and 6 events in the TH arm (2 distant recurrences, 3 local recurrences, and 1 contralateral breast cancer) have occurred. The 3 yr DFS for pts receiving T-DM1 was 97.5% (95% CI:95.9%-99.3%) and for TH was 93.2% (95%CI: 88.1%-98.7%).
Conclusion: This represents the first report of pts receiving T-DM1 monotherapy as adjuvant treatment for Stage I HER2+ BC. The regimen was associated with very few recurrences in the study population. T-DM1 was associated with significantly fewer CRT than TH, but did not meet the preplanned 40% relative reduction in toxicity. Updated efficacy data will be presented.
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MaggieCat--Thanks for posting. I'm confused by something. The number of disease-free survival (DFS) events was higher for TDM1 than TH, but the 3-yr DFS for TDM1 was better (97.5%) than for TH (93.2%)? Hard to decipher this when one has no scientific/medical background. Basically what I gather is both regimens are highly effective at achieving 3-yr survival; and TDM1 had lower toxicities (bad SEs) than TH, but the researchers expected even fewer toxicities on TDM1 than patients experienced. Is that right?
I see that 17% had to discontinue early--that includes me, because of my low platelet count. I wonder if that percentage surprised the researchers.
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What I can gather from articles about the TDM1 trial results announced this week is that the TDM1 regimen and the Taxol regimen have similar effectiveness. Good news for everyone on both arms of the trial--we were given good and effective treatments. Vast majority on both arms had no recurrence over 3 yrs. But TDM1 had more toxicities (side effects) than expected, and different ones from those produced by Taxol treatment. The study doesn't consider alopecia (hair loss)--which Taxol produces but TDM1 does not--but the lead researcher, Sara Tolaney of Dana Farber, said that this is an important side effect to the patients themselves and should be considered. So it seems maybe TDM1 will be offered as an alternative to Taxol--patients might be able to choose, based on what was learned about side effects--but not until further study. I have no medical background so don't take my word for it, but this is based on reading several online articles.
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Tolaney goes into a bit of detail - SE differences in the 2 arms (2:36)
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Wow... worth reading! Comments at the end mirror my thinking during those early years of participating ==> Quick opt out ( within ~ 3 months) T-DM1 arm experiencing significant SEs, especially for liver related SEs.
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I found these today.
https://www.targetedonc.com/conference/sabcs-2019/...https://www.healio.com/hematology-oncology/breast-...
https://www.medpagetoday.com/meetingcoverage/sabcs...
https://www.healio.com/hematology-oncology/breast-...
"To conclude, for early-stage disease, paclitaxel plus trastuzumab remains a standard of care and ado-trastuzumab should not be considered a standard at this time."
https://bcaction.org/2019/12/12/t-dm1-tradeoffs-no...
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Hi Isabel/Archer, Tiny Dancer, and Maggie/Cat!
I have been off here for many months but have returned after today's six month checkup. The doc was discussing my case with his new PA, and said the kind of BC I had (ER+/ HER2+) had a stronger recurrence rate over the first 5 years. I completed all but 2 of the TDM-1 treatments when, because of neuropathy, I left the trial and went on Herceptin.
After reading your comments I am comforted by the study results. For me, worrying is the worst side effect, although the neuropathy in my feet continues. My bloodwork and annual tomography were fine.
So, TinyDancer, I would lose those girl parts and not regret it. It's not like there's one scintilla of estrogen left in our bodies! (Does estrogen comes in scintillas?)
I was on AIs for 1-1/2 years and then Tamoxifen since then. AIs are strong and were hard, but your doc may switch yours if you have SEs. It’s definitely do-able for strong women like us.
Best of luck to all of you, and warm wishes for peace and happiness!
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Hello Ozoner! Good to hear you're well (but sorry to hear about the neuropathy!). You and I are among the 17% of TDM1 patients who had to go off early because of toxicities. But one of the next avenues of research may be testing TDM1 for a shorter treatment period--that would reduce toxicities. My onc told me the one-year time frame was just a guess anyway. But again, the good news is that the results--the prevention of cancer recurrence--were as good as could be.
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Wishing everyone a very Merry Christmas and Happy Holidays!
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As good as could be—a great way to put it!
🎄🎄 And I’ll add my wishes to all for a Merry Christmas!
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Hi all. I found this clearly stated summary of our clinical trial results--under the video you will see the transcript. The last sentence seems pretty key to me.
https://www.onclive.com/insights/her2-mbc/earlystage-her2-positive-breast-cancer-the-atempt-trial
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thanks for posting that summary! As one of the control group I was still eager to know the outcome. I’m happy for all of you tdm1ers as well as future women that the recurrence rates were not statistically different. Although disappointed up front to be assigned to conventional treatment, I ended up feeling just fine about it as even in our small group I saw that tdm1 wasn’t SE free for all. Other than hair loss, which was an interesting but temporary little adventure, my main SE was neuropathy in fingers and toes. It definitely interfered with my life and was a constant reminder of the cancer. But the amazing news is, that after over 4 years of steady unchanging symptoms, it has 99% resolved! It was not a gradual improvement over that time, but a fairly quick improvement that started about 3 months into a very low carb diet. I realized about a year into the eating change that it was essentially gone. Still get a tiny bit of pins and needles with cold but that’s it. I can now manage the tiniest earrings and buttons that so frustrated me for years. I can’t be sure the diet was responsible, but my oncologist said she’s never before seen improvement at that stage and agreed that since glucose is a neurotoxin, eating very low carb could be responsible for the healing. I’m finally feeling like this cancer adventure is well behind me I’m happy, fit and enjoying life fully! I wish the same for all of you!
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TTFan-- I'm thrilled to hear that your neuropathy is almost gone. That is amazing! And yes, we all--TDM1 ladies and Taxol ladies--got excellent and effective treatment, allowing us to enjoy life!
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